The Food and Drug Administration has changed its mind about a patch for injured knees, and withdrawn its approval for the product that was originally allowed on the market after four politicians from New Jersey pressured regulators into making their decision.

 

Menaflex Collagen Scaffold, manufactured by ReGen Biologics, should have been more thoroughly tested, said FDA officials this week. The about-face on Menaflex was a first in many ways for the FDA.

 

According to The New York Times, the agency “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

 

FDA scientists said they did not recommend Menaflex for approval. But higher-ups overruled the expert opinions after four Democrats from New Jersey—Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman—lobbied the FDA on the company’s behalf, and it was approved in December 2008. The FDA report also faults former FDA Commissioner Dr. Andrew von Eschenbach for becoming inappropriately involved in the approval process.

 

Gerald E. Bisbee Jr., chairman and chief executive of ReGen, said the company was still deciding whether to appeal the FDA’s decision. He pointed out that Menaflex has been available in Europe for nearly 10 years without any safety issues arising.

-Noel Brinkerhoff

 

F.D.A. Vows to Revoke Approval of Device (by Gardiner Harris, New York Times)

FDA Determines Knee Device Should Not Have Been Cleared for Marketing (Food and Drug Administration)

Review of the Regen Menaflex®*: Departures from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question (Food and Drug Administration) (pdf)